Cannabis for Opioid Use Disorder

PN
Overseen ByPaul Nuzzo
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Kentucky

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how cannabis can assist individuals with opioid use disorder by easing withdrawal symptoms, altering opioid effects, and ensuring safety. Researchers will administer both oral and inhaled cannabis to assess its impact. Participants will reside at the University of Kentucky Hospital for approximately six weeks. This trial targets individuals with moderate to severe opioid use disorder who experience withdrawal upon ceasing opioid use. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using cannabis for opioid use disorder involves certain risks and yields mixed results. Studies have found that cannabis does not enhance the quality of life or reduce hospital visits for individuals with opioid use disorder. Some research even suggests that cannabis users might be more likely to continue or start using opioids later.

Cannabis, especially in large amounts, can impair thinking and memory and may increase the risk of addiction. These side effects are important to consider when evaluating cannabis as a treatment option.

This trial is in its early stages (Phase 1) and primarily focuses on assessing the safety of cannabis. While some evidence exists from other uses, this trial will provide specific safety information for individuals with opioid use disorder.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using cannabis for opioid use disorder because, unlike traditional treatments like methadone or buprenorphine, cannabis offers a potentially new mechanism of action. Cannabis works on the body's endocannabinoid system, which may help reduce cravings and withdrawal symptoms differently than opioids. This alternative approach could offer relief to patients who do not respond well to existing therapies. Additionally, using cannabis could provide a more natural treatment option with fewer side effects, making it an appealing choice for those seeking holistic alternatives.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Research suggests that cannabis might help people with opioid use disorder by easing withdrawal symptoms, reducing cravings, and lowering anxiety. One study found that 73% of medical cannabis users either stopped or reduced their opioid use. Another study showed that people using cannabis for chronic pain reduced their opioid use by 40-60%. However, not all research agrees; some studies found no major impact on quality of life or relapse rates. Overall, while there are hopeful signs, the effectiveness of cannabis for treating opioid use disorder remains under investigation. Participants in this trial will receive either active oral cannabis or placebo oral cannabis to further explore these potential benefits.26789

Who Is on the Research Team?

SB

Shanna Babalonis, PhD

Principal Investigator

University of Kentucky College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with opioid use disorder who are otherwise healthy. Participants must be able to stay in the hospital for about 6 weeks and meet health requirements set by the study team.

Inclusion Criteria

Participants with moderate to severe opioid use disorder

Exclusion Criteria

Individuals who do not use opioids or do not experience opioid withdrawal when they stop using opioids

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Treatment

Participants live at the University of Kentucky Hospital for approximately 6 weeks, receiving repeated doses of oral cannabis and acute doses of oral and inhaled cannabis to study their effects on opioid withdrawal and administration.

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Inhaled Cannabis
  • Intranasal Opioid

Trial Overview

The study tests how different forms of cannabis (oral and inhaled) affect opioid withdrawal symptoms, responses to opioids given through the nose, and overall safety when both drugs are used together. All participants live at the hospital during the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral cannabis (active)Experimental Treatment2 Interventions
Group II: Oral cannabis (placebo)Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials
198
Recruited
224,000+

Citations

View of Cannabis for Opioid Use Disorder

No evidence of an impact of cannabis on quality of life, functioning, satisfaction, relapse, hospitalizations, or overdoses in people with opioid use disorder ...

The Role of Medicinal Cannabis as an Emerging Therapy for ...

These views on medicinal cannabis as a preferred analgesic do seem to translate to a reduction in prescription opioid use, with 69% of ...

Differential effect of cannabis use on opioid agonist ...

The current study did not demonstrate a statistically significant effect of cannabis use on outcomes of interest

For Opioid Use Disorder, Does Cannabis Produce Harm or ...

Cannabis users had 3.5 times greater odds of any opioid use and 2.6 times greater odds of new-onset opioid use 3 years later.

Cannabis Oil Adjunct for Opioid Use Disorder

This trial aims to test whether cannabis oil can safely and effectively support individuals currently using methadone therapy for opioid use disorder (OUD).

Cannabis for Opioid Use Disorder - NCBI Bookshelf - NIH

No evidence of an impact of cannabis on quality of life, functioning, satisfaction, relapse, hospitalizations, or overdoses in people with opioid use disorder ...

National Helpline for Mental Health, Drug, Alcohol Issues

National Helpline is a free, confidential, 24/7, 365-day-a-year treatment. Marijuana and CBD Hallucinogens Prescriptions and Opioids. Risks of ...

The efficacy and safety of cannabinoids for the treatment ...

Meta-analysis found no benefit of cannabinoids for opioid use disorder, tobacco use disorder, cocaine use disorder, bipolar disorder, anxiety, ...

Rationale for cannabis-based interventions in the opioid ...

Greater ORT success rates reduce the risk of those with opioid use disorder suffering a relapse and subsequent fatal overdose